Medication adherence monitoring system and method

ABSTRACT

A medication management system is described that is operable to determine whether a user is actually following a protocol, provide additional assistance to a user, starting with instructions, video instructions, and the like, and moving up to contact from a medication administrator if it is determined that the user would need such assistance in any medical adherence situation, including clinical trial settings, home care settings, healthcare administration locations, such as nursing homes, clinics, hospitals and the like. Suspicious activity on the part of a patient or other user of the system is identified and can be noted to a healthcare provider or other service provider where appropriate.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/985,285, filed May 21, 2018, now U.S. Pat. No. 10,475,533, issuedNov. 12, 2019 to Hanina et al., titled “Medication Adherence MonitoringSystem and Method”, which is a continuation of U.S. patent applicationSer. No. 15/618,944, filed Jun. 9, 2017, now U.S. Pat. No. 9,977,870,issued May 22, 2018 to Hanina et al., titled “Medication AdherenceMonitoring System and Method”, which is a continuation of U.S. patentapplication Ser. No. 14/735,394, filed Jun. 10, 2015, now U.S. Pat. No.9,679,113, issued Jun. 13, 2017 to Hanina et al., titled “MedicationAdherence Monitoring System and Method”, which claims the benefit ofU.S. Provisional Patent Application 62/010,983, filed Jun. 11, 2014 toHanina et al., titled “Medication Adherence Monitoring System andMethod,” each of which is incorporated herein by reference in itsentirety.

This invention was made with government support under grant number9R44TR000873-02 awarded by National Center for Advancing TranslationalSciences, National Institutes of Health. The Government has certainrights in the invention.

FIELD OF THE INVENTION

This invention relates generally to monitoring of patient adherence to amedication administration protocol, and more particularly to a systemand method for confirming whether a patient has properly administeredtheir medication according to a predetermined protocol, includingadvanced analysis and presentation features associated with confirmationof proper medication administration.

BACKGROUND OF THE INVENTION

Dr. Lars Osterberg, M.D. and Dr. Terence Blaschke have reported in theNew England Journal of Medicine, Adherence to Medication, (N Engl J Med2005; 353:487-97) 2005 an alarming lack of adherence to requiredmedication protocol, further noting that while the average rates ofadherence in clinical trials is categorized as “high”, this number stillcomprises only rates of 43 to 78 percent. Most importantly, the authorsnote “The ability of physicians to recognize nonadherence is poor, andinterventions to improve adherence have had mixed results.” Adherence,p. 487. The authors conclude “Poor adherence to medication regimens iscommon, contributing to substantial worsening of disease, death andincreased healthcare costs.” Adherence, p. 494. The Trend Repot Series,2008 Patient Adherence Update: New Approaches for Success, October 2008,report similar discouraging statistics. This broad range may possiblycontribute to the public confidence in the FDA approval process and theimportance of continued surveillance of a drug throughout the process.Furthermore, it may help to explain why, according to the Journal of theAmerican Medical Association (JAMA May 1, 2002), one out of every fivenew drugs that comes to market in the US is found to have serious orlife-threatening adverse effects—unknown or undisclosed at the time ofapproval. It is against this backdrop of poor adherence, and potentialdanger to patients, that the present invention operates.

It has been widely recognized that methods and systems for insuringproper medication ingestion or administration by individuals are veryimportant in defending against unnecessary sickness, deaths and otherproblems. Giving instructions and then letting patients fend forthemselves has been shown not to work particularly well. This is becauseit is not only the improper ingestion of medicines that is the primarycause of medical danger. Rather, an overall lack of sufficient patientguidance is also part of the problem. Further, the inability to confirma proper prescription regimen being provided to a user in the firstplace may cause a number of other problems with the use of suchmedication. As has been shown in regards to various public healthmedication administration situation, such as administration oftuberculosis medication by the WHO, Directly Observed Treatment (DOT)improves compliance of patients. Global Tuberculosis Control: A ShortUpdate to the 2009 Report, World Health Organization, 2009. As is shownin this report, funding for implementing DOT programs is high. Thus, theability to implement such a program with less of a financial burdenwould be desirable.

Traditionally, participants attend introductions and follow ups forclinical trials in-person. Other patients attempting to adhere to aparticular medication protocol similarly are given a prescription and aparticular set of instructions from a prescribing medical provider orprescribing doctor, and then compliance is measured at a next visit withthat prescribing professional through traditional methods of pillcounting, and patient interviews. Thus, data collection is similarlylimited to patient visits, rather than on a daily basis. These oldmethods such as patient questioning and pill counting have been provento be inadequate measures of adherence and offer no information on dosetiming and drug holidays (omission of medication for three or moresequential days).

Compliance technologies can increase the statistical power of clinicaltrials. Through the use of such technology, clinical events can beprecisely linked to medication use history. Captured data can be linkedto other sources such as EDC, patient diaries and data collected by thephysician. Technologies can create many possibilities for remote visitsand data capture. While smart packaging technologies exist such asRFID-enabled computer chip technology, smart blister packs and MEMS caps(microprocessor in a bottle cap), they are: a) invasive and need to bephysically attached to the medications; b) are non-conclusive regardingcompliance—a patient may activate the technology without ingestion ofthe medication; c) remain largely unadopted in clinical trials by thepharmaceutical and biotech companies due to their high cost; and d) takea longer time to implement. Further, electronic patient diaries allowfor ease of entry of data by a patient. These diaries, however, arestill subject to issues related to compliance with medication adherence.Thus, even if a patient is meticulous about entering information intothe diary, and thus complying with the requirements for data entry,there is still no guarantee that they are properly taking medication atprescribed times.

Jo Carol et al. stated that “The most reliable method for researchpurposes, although not practical in a clinical setting, may be acombination approach that includes pill counts, patient self-report, andelectronic monitoring.” (Carol J. et al, Patterns to AntiretroviralMedication, The Value of Electronic Monitoring, AIDS, 17 (12), pp.,763-767, October 2003). To date, technologies alone have only been usedto monitor compliance rather than to encourage it. Furthermore, therehas been no comprehensive system provided that allows for the managementof multiple patients and multiple patient populations. While currenttechnology may allow poor compliers to be recognized, as will bedescribed below, the proposed apparatus and method of the presentinvention will help to encourage pharmaceutical compliance and tacklesome of the problems that are encountered in the clinical trial processin particular, and the medication protocol monitoring problem ingeneral.

A number of systems exist that provide instructions to a user regardingwhen to take a medication and records when the user indicates that amedication has been taken. U.S. Pat. No. 7,359,214 describes such asystem. A device is provided that provides instruction to a patientregarding medications to take. Furthermore, the system may provide amethod for determining that the prescription is appropriate given thepatient's conditions, and other medications he or she may already betaking. The system may monitor the dispensing of medicine in accordancewith a predetermined treatment protocol. While such a system providesmany improvements for easing a burden on the patient, this systemsuffers in many ways and in particular in ways relevant to theadministration of clinical trials and other active patient monitoring ofmedication adherence.

Most importantly, this system provides no mechanism for actuallyconfirming that a patient is in fact ingesting or otherwise properlyadministering required medication as required in a clinical drug trial,as prescribed by a prescribing physician in the case where adherence toa particular regimen may prove to be critical to efficacy of theprescription regimen, in various public health scenarios, in situationswhere failure to keep up a prescription regimen can potentially harm apopulation as a whole, such as the generation of antibiotic-resistantbacteria strains, in various disease management scenarios, or in homecare situations where maintaining proper control of administeringhealthcare professionals is critical. Further, while the system may besufficient for one who is in full possession of their mental faculties,any individual who may have difficulty following directions, or one whois actively avoiding medication may still not be taking requiredmedication after it is dispensed. Thus, participants may be forgetful,visually impaired, or otherwise do not believe in the benefit of takingsuch medication, and may thus not properly log medicationadministration. Furthermore, the system requires preloading of variousmedications into a dispenser, and thus likely requires regular visits byan administering manager to be sure appropriate medications are in factproperly loaded therein. It is surely possible that an inexperienceduser may place incorrect medications into the device, or may somehowprovide incorrect dosages into the device. Additionally, for potentiallymore complex regimens, there is no method provided for insuring that auser is able to follow such a protocol, and to thereafter confirm thatthe user has in fact taken all required medications in accordance withany provided instructions or the like, or has taken the medicationsaccording to one or more specifications or followed suggestedprocedures. Finally, this system is expensive and requires constantmaintenance to confirm that the various mechanical parts are in workingorder.

U.S. patent application Ser. No. 11/839,723, filed Aug. 16, 2007, titledMobile Wireless Medication Management System, provides a medicationmanagement system employing mobile devices and an imaging technology sothat a user is able to show a pill to be taken to the system, and thesystem can then identify the medication. Patient histories are availableto an administrator, including various vital signs as measured by thesystem. Images may also be taken of the patient, provider, medicationcontainer or the like. While the system professes to ensure adherence toa protocol, the system only provides such help if requested by a user.There is in fact no particular manner in which to ensure actualadherence or ingestion of the medication, or the relationship ofadherence to the efficacy or safety of the drug over time. Whenrequiring adherence to a predetermined protocol for a clinical trial,this is particularly relevant.

Additionally, existing systems fail to maintain an audit trail for postadministration review by a medical official or other clinical trialadministrator, and further cannot therefore confirm confirmation ofproper medication administration or population management.

Therefore, it would be desirable to provide an apparatus that overcomesthe drawbacks of the prior art.

SUMMARY OF THE INVENTION

In U.S. patent application Ser. No. 12/620,686, filed Nov. 18, 2009,titled Method and Apparatus for Verification of MedicationAdministration Adherence; abandoned, U.S. patent application Ser. No.13/588,377, filed Jul. 26, 2012, titled Method and Apparatus forVerification of Medication Administration, currently pending, U.S.patent application Ser. No. 12/646,383, filed Dec. 23, 2009, titledMethod and Apparatus for Verification of Clinical Trial Adherence,abandoned; U.S. patent application Ser. No. 13/558,380, filed Jul. 26,2012, titled Method and Apparatus for Verification of Clinical TrialAdherence, now U.S. Pat. No. 8,731,961; U.S. patent application Ser. No.14/244,036, filed Apr. 3, 2014, titled Method and Apparatus forVerification of Medication Adherence, currently pending; U.S. patentapplication Ser. No. 12/646,603, filed Dec. 23, 2009, titled Method andApparatus for Management of Clinical Trials, now U.S. Pat. No.8,666,781; U.S. patent application Ser. No. 14/153,042, filed Jan. 12,2014, titled Apparatus and Method for Managing Medication Adherence,currently pending; U.S. patent application Ser. No. 12/728,721, filedMar. 22, 2010, titled Apparatus and Method for Collection of ProtocolAdherence Data, currently pending; U.S. patent application Ser. No.12/815,037, filed Jun. 14, 2010, titled Apparatus and Method forRecognition of Patient Activities When Obtaining Protocol AdherenceData, currently pending; U.S. patent application Ser. No. 12/899,510,filed Oct. 6, 2010, titled Apparatus and Method for Assisting Monitoringof Medication Adherence, now U.S. Pat. No. 8,605,165; U.S. patentapplication Ser. No. 14/073,525, filed Nov. 6, 2013, titled Apparatusand Method for Monitoring of Medication Adherence, currently pending;U.S. patent application Ser. No. 13/189,518, filed Jul. 24, 2011, titledMethod and Apparatus for Monitoring Medication Adherence, currentlypending; U.S. patent application Ser. No. 13/235,387, filed Sep. 18,2011, titled Apparatus and Method for Recognition of Patient Activities,currently pending; U.S. patent application Ser. No. 13/214,201, filedAug. 21, 2011, titled Apparatus and Method for Determination ofMedication Location, currently pending; U.S. patent application Ser. No.13/674,209, filed Nov. 12, 2012, titled Method and Apparatus forIdentification, currently pending; and U.S. patent application Ser. No.13/831,555, titled Apparatus and Method for Recognition of SuspiciousActivities, currently pending; the contents of these applications beingincorporated herein by reference, a proposed system, method andapparatus allows for complete control and verification of adherence to aprescribed medication protocol or machine or apparatus use, whether in ahealth care provider's care, or when self-administered in a homecaresituation by a patient.

These applications present a medication management system that maydetermine whether a user is actually following a protocol, provideadditional assistance to a user, starting with instructions, videoinstructions, and the like, and moving up to contact from a medicationadministrator if it is determined that the user would need suchassistance in any medical adherence situation, including clinical trialsettings, home care settings, healthcare administration locations, suchas nursing homes, clinics, hospitals and the like. Further, inaccordance with present invention, suspicious activity on the part of apatient or other user of the system can be determined, and can be notedto a healthcare provider or other service provider where appropriate.

In accordance with an embodiment of the present invention, one or morestatistical or other calculations related to medication adherence may beperformed, the results of such calculations preferably being displayedto a healthcare provider on a dashboard or other display, the resultsfurther preferably initiating one or more automated sequences forassisting in encouraging medication adherence.

Still other aspects, features and advantages of the invention will inpart be obvious and will in part be apparent from the specification anddrawings.

The invention accordingly comprises the several steps and the relationof one or more of such steps with respect to each of the others, and theapparatus embodying features of construction, combinations of elementsand arrangement of parts that are adapted to affect such steps, all asexemplified in the following detailed disclosure, and the scope of theinvention will be indicated in the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the invention, reference is made tothe following description and accompanying drawings, in which:

FIG. 1 is a flowchart diagram depicting a method in accordance with anembodiment of the invention;

FIG. 2 is a flowchart diagram depicting a method for determining whethera user has taken a pill in accordance with an embodiment of theinvention;

FIG. 3 is a flowchart diagram depicting an additional method fordetermining whether a user has taken a pill in accordance with anembodiment of the invention;

FIG. 4 is a flowchart diagram depicting a process for monitoringmedication adherence in accordance with an embodiment of the invention;and

FIG. 5 depicts an exemplary hardware platform for implementation of oneor more of the embodiments of the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The invention will now be described making reference to the followingdrawings in which like reference numbers denote like structure or steps.Embodiments of the invention can be implemented on a hardware platformthat includes an image capture device. Examples of a hardware platforminclude a smart phone, a desktop computer, a laptop computer, a tabletdevice, a wearable device such as a smart watch, or any other suitableelectronic device. Examples of an image capture device include a cameraor scanner and may employ technologies such as CMOS or CCD imagesensors, and may be based, for example, on techniques using lasers,radar, infra-red (IR) radiation, ultra-violet (UV) radiation,time-of-flight (TOF) sensing techniques, depth perception techniques, orany other suitable device, technologies and techniques that can captureand/or store images and/or videos. While applicable to various platformsand image capture devices, embodiments of the present invention areparticularly useful in situations where resolution of an image capturedevice, such as a web cam, is limited and/or where processing power of ahardware platform, such as a mobile device, is limited.

Referring first to FIG. 1, a data flow overview in accordance with theoperation of an embodiment of the present invention is shown. Inaccordance with this embodiment of the invention, information about aparticular drug to be the subject of a clinical trial, to be employed ina public health or disease management situation, or the like, othermedication administration program or prescription, or other patientself-administered medical task such as performing a home based urinetest or the like may be provided in a database 105, and existingindustry medication information databases 110 are preferably employed toaccess prescription, interaction, application, and other availableinformation about any number of proposed prescription andnon-prescription medications and their possible interaction with theclinical trial or other medications. Further, patient medical records115 may be used, and as will be described below, in conjunction with theindustry medical information and a medical professional's prescribingexpertise to confirm that a patient is a good candidate for such aclinical trial, or medication administration program. These databasesmay be accessed in a manner known to one of ordinary skill in the art.

Additionally, one or more predetermined likely typical elements ofsuspicious or malicious behavior may be provided. Such elements may bebased upon the type of medication, method of medication administration,demographics or other information about the patient, other features, ora combination of these elements. Such suspicious activities may furtherbe determined based upon patient profiling of patients, historicaldetermination of likely suspicious activities, prior activity of theparticular patient or similarly-situated patients, and the like. Otherpopulation based metrics may also be employed, including but not limitedto sporadic administration times, suspicious administration times, tooshort times on task, inconsistent times on task, and any other metricmeasured from a population found to correlate with predictive suspiciousbehavior on the part of the participant or patient. Measurement ofwhether the patient has any medication in their blood, and to the extentno such medication is determined to be in the blood of the patient, thedetermined suspicious activities may be confirmed to correlate with lackof medication. This correlation may be determined in accordance withvarious artificial intelligence features, or with one or moresupervised, unsupervised, or deep learning techniques. This determinedcorrelation may then be used in the future to infer that the existenceof these suspicious activities is predictive of failure to takemedication. Suspicious activity information 118 is therefore preferablytransferred to the system at this time as well, and as noted above mayinclude one or more indications of patient movements or other actionsthat may indicate suspicious behavior on behalf of the patient, amalicious intent to trick the system, or actions of other high riskpopulation. The various embodiments of the present invention may also beprovided to determine if a patient is performing an action or taskcorrectly or if they are simply making a mistake.

Once confirmed, a medication administration and ingestion or othermedication regimen in accordance with the clinical trial or otherprescription requirements such as in a public health, medical practiceenvironment or the like may be prescribed and entered into the system ofthe invention at 120. Such medication administration regimen may includeone or more of ingesting or swallowing a pill, using an inhaler device,using an injectable medication device, employing a patch, sublingualadministration, a cheek or other skin located medication administrationdevice or the like. The prescription regimen may also comprise one ormore pre-administration steps, such as monitoring a medical apparatus,such as a heart rate monitor, blood pressure monitor, glucose monitor,or any other monitor or system that provides an output that potentiallyeffects a medication administration process.

Once entered into the system, a particular prescription regimen maycause a set of user instructions, various training sequences and thelike 125 to be generated and transmitted to an apparatus provided to apatient in accordance with an embodiment of the invention for access tothe system of the invention. Such an apparatus may comprise a customdesigned video and audio capture, analysis and transmission apparatus, asmart phone or other mobile device including an image capture devicesuch as a camera or other video and audio capture apparatuses, anetbook, laptop computer, desktop computer, tablet device or the like,free standing, or built into a mirror or cabinet or the like, or othercomputing appliance allowing for the display of instructions to apatient, and allowing for the eventual capture, analysis andtransmission of video, audio and other analysis information. Additionaldevices, including one or more wearable sensors, such as a watch with acamera or other sensor, Google Glass®, or other monitoring device may beemployed. When installing software on a user's own hardware system, itis preferred that the software detect and otherwise test or determinethat the hardware attempting to be utilized by the patient is sufficientto implement the invention and is sufficient to run a software packageprovided in accordance with the invention. Thus, the software may checkthat an image capture device such as a camera includes sufficientresolution, that a memory of the device is of sufficient size to allowfor sufficient captured video storage, that audio may be properlycaptured, and that the transmission system includes sufficient bandwidthto transmit and receive captured video, audio, video instructions andthe like. Processing may also be performed at a remote location, thusallowing the user to include a lighter application or the like on theirlocal device. Alternatively, the user may employ the local device as agateway only, all data being transmitted to a remote location forprocessing, and returning responses as a result of such processing.Thus, a user may be able to dial up a video conference number, orotherwise interact with a remote site, such as by visiting a particularwebsite or URL.

In various alternative embodiments, one or more of the steps noted abovemay be excluded. For example, a predefined set of user instructions maybe provided to all users, such as in a clinical trial or the like. Thus,rather than customizing the user instructions for each individual user,such instructions may be provided for a particular predetermined segmentof the population, based upon demographics or other factors, or a singleset of instructions may be provided for all users prescribed aparticular medication or sequence of medications.

The noted user instructions and training sequences may include generalinstructions about the particular medication subject to the currenttrial or medication administration protocol, methods for administration,warnings about side effects, and concerns about drug interactions withcommon substances or medications, or other medications prescribed to thepatient by the system or by another medical service provider. It iscontemplated in accordance with an embodiment of the invention that suchset of user instructions may be interactive, allowing a user to viewadditional information about such instructions or prescriptions asdesired. These instructions may comprise written, audio or videoinstructions provided to the user on a display or other informationpresentation device of the user apparatus. The instructions for aparticular user may also be adherence dependent, i.e. if a user has beennon-adherent, content describing the importance of good medicationadherence, and possibly asking the user for reasons for the adherencemay be presented as part of the instructions. Thus, the user may beprovided with content at the time of medication administration relatedto their historical success with medication administration.

It is further contemplated that such instructions may indicate one ormore movement sequences to be associated with a corresponding one ormore medication administration sequences. These instructions preferablyindicate proper and improper motions that may be taken by a patient foringesting a pill, using an inhaler, using an injectable medication, andthe like, and may indicate various motions that may or may not beperformed by a user. In such a manner, the patient may be instructed toproperly perform all requested actions, and avoid actions that may beindicative of a patient trying to trick the system. The system may beemployed in an augmented reality scenario, allowing for active followingof medication administration, providing an event for complete, nearlycontinuous feedback loop.

In an alternative embodiment, it may be possible to particularly notdescribe to the patient the various suspicious behaviors that will betracked in an attempt to “trap” the unsuspecting malicious patient.These traps may be maintained and running in a background of the system.Thus, as will be described below, detection of one or more errors maygenerate real time displayed video and/or audio feedback to the patientin order to correct actions, while one or more other errors may belogged by the system but preferably provide no feedback to the patient,and thus may be accumulated and used to analyze patient actions withoutproviding instructions and help to avoid being caught by the system.After being “caught” a number of times, a state of the user may bechanged to one of heightened security awareness. Thus, a user may befirst started in a low level of observation. After a predeterminednumber of potentially actions that are caught, the user may be labeledas a user that is attempting to trick the system, or that is performingone or more suspicious acts, thus warranting a heightened level ofsecurity. Additional suspicion will surround review of all actions ofthe patient. After properly using the system correctly for anotherpredetermined period of time, the user may be returned to the initialnormal state. If on the other hand, suspicious activity continues, theuser may be moved to yet another state where the user may be recommendedto be removed from a clinical trial, or taken off a particularmedication, for example.

Such suspicious activity determination may further be performed basedupon information retrieved from a plurality of patients in the sameclinical trial, taking the same medication, or from a population atlarge. Any of these group may be further segmented, for example, bydemographics and/or adherence levels, in order to aid in determining anappropriate level of surveillance and feedback to be provided to thegroup. As noted above, this feedback may be provided in the case thatthe user improperly administers their medication. The user can then beprompted to properly administer their medication by following thesubsequent further instructions. The system may then preferably confirmthat the user has properly taken their medication by following thefurther instructions.

In accordance with one or more embodiments of the present invention, oneor more of these sets of motions or actions may comprise confirmationthat a user has placed a pill in their mouth and has swallowed the pillcorrectly and has therefore ingested the medication properly throughvisual confirmation of location, confirmation that the user has properlyused an inhaler device through visual confirmation of position and/oraudio confirmation of actuation, confirmation that the user has properlyused an injectable device through visual confirmation of position and/oraudio confirmation of actuation, or the like. Various micro-movementsmay also be tracked and determined in accordance with the invention.Such micro-movements may include, for example, one or more ofswallowing, hand gesture, and/or facial expressions. Faking or mimingmay be further determined through analysis of these micro movements. Adetermination of improper medication administration may generatewarnings, and further instructions to aid in encouraging the user toproperly administer the medication, as noted above. A deep learning, orother supervised or unsupervised learning process may be employed inorder to aid in training the system, or in order to improve recognitiontechniques. In general, deep learning refers to a subfield of machinelearning that focuses on learning multiple levels of featurerepresentations in order to model complex relationships among data suchas images, sound, and text. Deep learning provides methods forsupervised or unsupervised learning of feature representations atsuccessively higher, more abstract levels. Embodiments of the currentinvention may employ deep learning to help the system to learn complexactions of interest such as micro-movements in conjunction with othermotions or actions of a user in order to monitor and detect impropermotions.

Referring next to FIG. 2, a more detailed description of determiningwhether a user has properly put a pill in their mouth employing adecision fusion process is shown. As is shown in FIG. 2, once an imageor plurality of images of the user taking a pill are captured by amobile device or other image capture device, at step 210 the images arescanned to confirm that the face of a user is in the images. At step 215it is queried whether the user's face is in the images. If this inquiryis answered in the negative, and it is confirmed that the user's face isnot in the images, then at step 220 further instructions are provided tothe user to aid them in properly performing the step of properly placingtheir face in the image, while processing returns to step 210 to acquirea further image or plurality of images.

If the inquiry at step 215 is answered in the affirmative and it istherefore confirmed that the user's face is present and viewable in theimages, then processing passes to step 225, where an open mouth of theuser is looked for in a further image or plurality of images. Thus atstep 230 it is inquired whether the open mouth of the user is able to bedetected in the image or images acquired at step 225. If this inquiry isanswered in the negative, and it is confirmed that the user's open mouthcannot be detected in the images, then at step 235 further instructionsare provided to the user to aid them in properly performing the step ofproperly showing their open mouth in the images, while processingreturns to step 225 to acquire a further image or plurality of images.

If the inquiry at step 230 is answered in the affirmative and it istherefore confirmed that the user's face is present and viewable in theimages, then processing passes to step 240 where an image or pluralityof images are acquired to determine whether there is a pill in the mouthof the user. Thus, at step 245 it is inquired whether the pill is foundin the mouth of the user. If this inquiry is answered in the negative,and it is therefore determined that there is not a pill (or anythingelse) in the mouth of the user, then processing passes to step 250 wherefurther instructions are provide to the user to aid in properly placethe pill in their mouth and properly place their face and mouth in thedisplay to allow for proper confirmation that the pill is present intheir mouth.

If the inquiry at step 245 is answered in the affirmative, and it istherefore confirmed that there is a pill or something else in the mouthof the user, processing then passes to step 255 where a featureextraction process is preferably undertaken. In a preferred embodiment,up to four or more features may be extracted, the more featuresemployed, the greater the potential accuracy of the system. Therefore,at step 260, other features, such as marking or other distinctivefeatures may be extracted. At step 270, one or more color features maybe extracted, at step 280 one or more texture features may be extracted,and at step 290 one or more shape features may be extracted. Atcorresponding steps 265, 275, 285 and 295, one or more confidence scoresmay be determined in accordance with the various feature extractions.Then at step 297, preferably a decision fusion algorithm employing oneor more of the determined confidence scores is employed to result in anoutput at step 299 to confirm whether the pill placed in the mouth ofthe user is the correct and expected pill. This process may also beemployed to identify a pill within the mouth of the user if the featuresextracted are then compared to a library of features in steps 265, 275,285 and 295, thus allowing for a selection of a best match from alibrary of pills, other objects, or the other medications as the casemay be. Alternatively or additionally, the system may check thepackaging in which the pill is provided to further confirm that the useris administering the proper medication. The system would therefore readtext, barcodes, or other indicia on the packaging to recognize andconfirm the identity of the medication. Upon removal, the pill may betracked through the various screens, and the gesture of the hand orother body part of the user may be tracked to further ensure that themedication is removed from the packaging and then properly administeredby the user without the possibility of the user not properlyadministering the medication.

Referring next to FIG. 3, a further embodiment of the invention fordetermining whether a user has placed a pill in their mouth employingfeature fusion process is shown. The steps 210-255 are similar to thoseshown in FIG. 2, and will therefore not be described herein. Afterfeatures are extracted at step 255, these features are confirmed asother features (such as pill markings and the like) at step 360, colorfeatures at step 370, texture features at step 380 and shape features atstep 390. Other features may also be employed as appropriate. After allof these features are extracted, they are fed into a feature fusionalgorithm at step 397, the output of which determines whether a correctpill or other object is in the mouth of the user at step 399. Similarlyto as noted above, this feature fusion process may also be employed todetermine the identity of one or more pills or other objects from agroup of known pills, or from a library of a large number of pills.Furthermore, if a new pill is determined, it is possible to retain thisinformation to allow for a future recognition of the same pill. Thus theacquired extracted features may be used to train or further refine anyrecognition data employed for pill recognition.

In accordance with the various recognition steps employed in accordancewith the various embodiments of the invention, various requests may bemade of the user in order to attempt to improve the recognition process.These requests all aid to improve the ability of the camera to properlyview the pill in the mouth of the user, and to improve the imagingenvironment in which the camera is to work. In accordance with thevarious embodiments of the invention, detailed modeling of the mouth,tongue, teeth, lips and/or gums may be employed. In such a manner, it istherefore possible to extract any such feature if it interferes with thedetection of the pill or other object in the mouth. For example, if thepill is white, it may be preferable to extract the teeth of the user toavoid any confusion with the pill. Similar extractions may be employedwith the other portions of the mouth of the user based upon the color orother features of the pill. Such detailed modeling is also beneficialwhen determining whether the user has placed the pill or othermedication in the correct location in their mouth, such as when the useris to take a sublingual medication that must be positioned under totongue to properly dissolve. Such extraction may also be applied totongue piercings dental fillings, and any other features that may tendto complicate or confuse the pill or medication recognition process.

As noted, such detailed modeling allows for the determination oflocation of the pill or other medication in the mouth. Thus, properplacement of the pill is important. Additionally, when scanning themouth, such detailed modeling may also allow for a determination thatthe user is hiding the pill in a portion of their mouth to avoid takingthe medication. Such recognition may be employed to false an alert (in amanner as will be described below) or may be employed to decrease theconfidence of any determined medication administration. Thus, the usermay be asked to move their tongue up or down in their mouth to allow fora clear view of the mouth to scan for a pill that is supposed to beswallowed. Failure to move the tongue as requested may be logged as asuspicious activity. By modeling the tongue in this manner, it ispossible to make detailed determinations of whether the user is properlymoving their tongue, and whether they appear to be attempting to hide apill in their mouth. Additionally, any type of deformation of the cheekor mouth area may be recognized to aid in determining that the user istrying to disguise a movement or motion. Requests for such movement maybe provided at any of the instruction steps in FIGS. 2 and 3, and mostpreferably at step 250 in FIGS. 2 and 3. Various other portions of themouth may be examined to determine an intent to trick the system, suchas any deformation of the cheek of the user that may be attempting tohide a pill or other object therein. Other locations in the mouth mayalso reviewed to confirm that the pill is not being hidden.

In addition to directly employing the noted visual algorithms, it ispossible to employ a number of other checks to aid in determining thatthe user is properly taking their medication, or alternatively that theuser is attempting to trick the system. Thus, in addition to employingaudio to listen for the user to spit out the pill or otherwise tracknoise indicative of the user trying to trick the system. The user may beasked to speak a predetermined word on sentence to determine whetherthere is any distortion in the audio. Such a system may be employed byasking the user to say the sentence in a training session, either whenin the presence of a healthcare worker, or alone, so that there is acomparison that is possible at the later time. In such a manner, theseadditional features assist in determining whether a user is attemptingto trick the system.

In addition to the direct monitoring of one or more parameters relatedto the actual ingestion of a medication pill or other object, it isfurther possible to monitor emotions of the user, any edginess, rapideye movements, or other actions that may lead to a determination thatthe user is acting untruthfully, or is trying to trick the system. Othermonitored movements on the part of the user may comprise swiping of theuser's hand over their mouth when the pill has been placed therein,wiping of the mouth, turning of the user's head relative to the camerain an attempt to shield the mouth, not properly tilting the cup whendrinking, and therefore pretending to drink or “drink miming”, and thelike. These movements may also be tracked and monitored in order tofurther determine proper medication administration, including placingand keeping the medication pill in the mouth.

Various additional features may preferably be provided in order to allowsignificant flexibility in the monitoring of confirming medication pillsare ingested by a user. Thus the system can be provided to trackmultiple pills for a single administration, multiple types ofmedication. Environmental checking to confirm the lighting environmentis appropriate for the camera (and providing feedback instructions ifthere is a parameter that needs to change), as well as flashing thedisplay to provide additional light to support low ambient light mayalso be provided in order to aid in the functionality of the system.

As noted above, various attributes, such as video and/or audio dataindicative of different levels of, for example, stress, anxiety, energy,movement, tone of voice, and/or speed of talking, may be employed inorder to determine whether the user is performing in a manner thatsuggests possible attempts to cheat the system. These attributes mayfurther be cross-correlated with known, monitored adherence informationand any other questionnaires in order to determine any patterns betweenmeasurable behavior and the known adherence profile of the user. Suchquestionnaires may be presented in visual format, or via an interactivevoice recognition system, thus allowing for questions to be presented atthe time of poor adherence or the like. Such questions may prompt forinformation, or an emotional response that may further be correlated tothe adherence profile of the user. Responses, or even additionaltargeted questions may be employed to prompt more favorable behaviorpatterns from the user. Thus, if particular attributes are determined inthe future, it would be possible to increase surveillance, or otherwiseattempt to intervene to improve actual adherence, based upon thesefindings.

In addition, the system may preferably include one or more additionalquestions that may be provided to the user if any such increasedsurveillance is necessary, thus trying to ascertain one or more reasonsfor the poor adherence behavior. Simple or complex questions can beasked, the responses being provided into a system that further is ableto predict user behavior. Various emotional responses may be elicited,thus allowing for the determination of whether the user is likely totake their medication in the future. By employing such predictivealgorithms, the user may be positioned within a predetermined statemachine or other system for predicting behavior based upon historicaldata, thus allowing for necessary intervention and escalation when pooradherence is predicted. In this manner, the users may be contactedbefore they fail to take their medication. If such a possibility of pooradherence is determined, and thus intervention may be consideredhelpful, a customized intervention form a healthcare provider may beprovided. This interaction may include automated contact, personalcontact, education, incentives and other methods or features toencouraging proper medication adherence. Success or failure of each ofthese intervention methods may further be tracked and provided asfeedback information, thus further allowing for customization and finetuning of the intervention strategies in the future.

Additional details regarding the modeling and monitoring of positionsand movements of the mouth and tongue of the user as well as other micromovements, micro bulges, and micro expressions of the user may also beemployed. For example, various machine learning techniques may beemployed in order to map and track the position of the tongue. Thesemachine learning techniques may include one or more supervised orunsupervised learning techniques, such as deep learning techniques. Inaddition to modeling the mouth and tongue of the user, these additionallearning techniques may be employed for feature recognition at the timeof training the system, as well as for data analysis at the time ofsystem use. Various quadrants may be defined in the mouth of the user,and thus positioning of the tongue may be determined with accuracy, andutilized to further determine proper medication adherence, or an intentto try to trick the system.

Referring back to FIG. 1, at step 130, confirmation of medication ispreferably performed employing computer vision and identification in amanner consistent with the device noted above. Adherence is similarlyverified in accordance with computer vision and activity recognition.Finally, review, either automated and/or manual is performed of theadherence and confirmation information, and intervention is provided tothe user. Details of these confirmation and intervention steps will nowbe provided.

Referring next to FIG. 4, a flowchart diagram depicting one possibleexemplary flow of processing in accordance with an embodiment of theinvention is shown. As shown in FIG. 4, at step 410, a user may be askedto place their face in a display positioned according to one or moreinstructions, prompts, masks, or the like on the display or a devicecoupled to, or including a camera for imaging. Processing passes to step415 where it is determined whether the user has placed their face in thecorrect location on the display. If this query is answered in thenegative, and it is determined that the user has not placed their facein the proper location, one or more further instructions may be providedat step 418 to aid in encouraging the user to properly perform thecurrent step, before moving on to the next step. The loop of steps 410,415 and 418 may continue until the inquiry at step 415 is answered inthe affirmative, and it is therefore determined that the user hasproperly placed their face in the display.

Processing then passes to step 420, where the user may be asked to placethe medication pill (or other medication) in the display positionedaccording to one or more instructions, prompts, masks, or the like onthe display or a device coupled to, or including a camera for imaging.Processing passes to step 425 where it is determined whether the userhas placed the pill in the correct location on the display. If thisquery is answered in the negative, and it is determined that the userhas not placed the pill in the proper location, one or more furtherinstructions may be provided at step 428 to aid in encouraging the userto properly perform the current step, before moving on to the next step.The loop of steps 420, 425 and 428 may continue until the inquiry atstep 425 is answered in the affirmative, and it is therefore determinedthat the user has properly placed the pill in the display.

Processing then passes to step 430 where the user may be asked to showthe pill or other medication in their mouth and show this position tothe camera to be shown in the display positioned according to one ormore instructions, prompts, masks, or the like on the display or adevice coupled to, or including a camera for imaging. Processing passesto step 435 where it is determined whether the user has placed the pillproperly in their mouth and shown the placement properly to the display.If this query is answered in the negative, and it is determined that theuser has not properly placed the pill in their mouth and shown this tothe camera at the proper location of the display, one or more furtherinstructions may be provided at step 438 to aid in encouraging the userto properly perform the current step, before moving on to the next step.The loop of steps 430, 435 and 438 may continue until the inquiry atstep 435 is answered in the affirmative, and it is therefore determinedthat the user has properly placed the pill in their mouth and shown thepill-in-mouth to the display.

Processing then passes to step 440 where the user may be asked to drinka glass of water or other liquid in the display positioned according toone or more instructions, prompts, masks, or the like on the display ora device coupled to, or including a camera for imaging. If the user isnot using a clear cup, the user may be prompted to use a clear cup sothat it can be seen if the user spits the pill out of the user's mouthand hides it inside the cup. If the user does not change the cup, analert may be provided indicating potentially suspicious behavior.Processing passes to step 445 where it is determined whether the userhas properly drank the glass of water in the correct location on thedisplay. If this query is answered in the negative, and it is determinedthat the user has not drank the glass of water, one or more furtherinstructions may be provided at step 448 to aid in encouraging the userto properly perform the current step, before moving on to the next step.The loop of steps 440, 445 and 448 may continue until the inquiry atstep 445 is answered in the affirmative, and it is therefore determinedthat the user has properly drank the glass of water in the display.

Finally, processing passes to step 450 where the user may be asked toshow their empty mouth to the camera to be shown in the displaypositioned according to one or more instructions, prompts, masks, or thelike on the display or a device coupled to, or including a camera forimaging. Processing passes to step 455 where it is determined whetherthe user has properly shown their empty mouth to the display. If thisquery is answered in the negative, and it is determined that the userhas not properly shown their empty mouth at the proper location on thedisplay, or it is determined that their mouth is not empty, one or morefurther instructions may be provided at step 458 to aid in encouragingthe user to properly perform the current step, before moving on to thenext step. Alternatively or additionally, the user may be asked to showthe glass of water so that it can be confirmed (for example, through theclear side of the glass or from the top of the glass) that the pill hadnot been spit out of the mouth of the user. The loop of steps 450, 455and 458 may continue until the inquiry at step 455 is answered in theaffirmative, and it is therefore determined that the user has properlyshown their empty mouth and/or the glass of water without the pillinside to the display.

In accordance with various alternative embodiments of the invention, anyone or more of the steps may be excluded, preferably based upon adesired level of surveillance, but may be based upon any reason.Additionally, while the example is shown with a single medication pill,multiple of the same or different pills may be employed, as may one ormore sublingual or other medications.

Therefore, in accordance with one or more embodiments of the invention,the following results, among others, may be achieved.

1. Analyze audio sound to determine if pill still in mouth—After placingthe pill in their mouth, swallowing the pill and confirming their mouthis empty, the system may ask the user to speak something. This wordingmay be prerecorded by the user so that a comparison with current audiomay be made. The audio will be recorded and analyzed. If the sound isabnormal, a suspicious flag will be raised on the dashboard for humaninspection.

2. Measure the time the user drinks the water—The time on task data ofdrinking the water may be monitored and be used by the system todetermine if the patient is faking drinking the water. If the time ontask is too short comparing with other people, or prior steps performedby the same person, this may suggest the user is cheating. Also, thesystem can check the water level in the cup as a secondary check. Toautomate the process, the system can ask the user to show the cup withwater. The system may detect the cup and water level and saves the timeas start time. After drinking water, the system may ask user to show thecup again. And saves the time as end time. The time difference can beused to determine if drinking water is too fast.

3. Sound detection for detecting spitting the pill. Sound will berecorded and analyzed at critical steps. If spitting sound is detected,suspicious flag will be raised.

4. Detect hand to mouth at critical steps—At critical steps, the systemwill look for hand around mouth regions. If hand is detected at thosecritical steps, suspicious flag will be raised.

5. Use reflections of the screen to help pill in mouth confirmation orempty mouth confirmation in dark environment. If a room is dark, thesystem may have a problem seeing what is in the mouth of the user. Thesystem is then able to analyze the brightness of environment. If thebrightness level is below a threshold, the system will ask the user tocome closer to the screen and open their mouth. In this situation, theface will be missing, leaving the open mouth showing on the majority ofthe screen. Then the system will detect the open mouth and check what isin the mouth with the help of reflections from the screen. The screenmay be flashed or lit around the perimeter to provide adequate lightingto light the scene.

6. Multiscale detection and fusion to check what is in the mouth. Thisprocess can help to make sure it is the right pill in the mouth and canbe used to check whether it is dented pill, tongue piercing, teeth orthe wrong pill. This process has been described above with respect toFIGS. 2 and 3.

7. Determine duplicate enrollment of a user. Through the analysis ofimages of the face or other biometric marker of the user, it is possibleto determine within a larger group of users whether a particular userhas been entered into the system twice. Thus, determining whether theuser has a very similar second user in the system may be determined, andthen provided to a live operator to confirm whether there is aconfirmation that the user has entered the system twice. While thisfinal confirmation may be provided via an automated system, theinventors of the current invention have determined that the use of amanual review after proper prompting by the system allows for a secondcheck of the potential duplicate enrollment, encouraging a failsafeprocess. The automated notification to the manual review may beperformed in accordance with a deep learning, supervised, orunsupervised learning and/or analysis process. One or more dashboardsmay be provided allowing for the review of images or videos of thepotentially duplicate enrolled users. Such dashboards, may provide anautomated system to provide a review of such images, or may provide aplatform by which a manual user may provide such comparisons.

In various additional embodiments of the invention, the system ispreferably adapted to recognize one or more different medications, aswell as count a plurality of the same or different pills or othermedication administrations. In addition to imaging and recognizing theactual medication, it is also contemplated to allow the system to imageand recognize one or more medication bottles, labels or other indicator.This recognition may be employed as a secondary check that themedication is correct, may be substituted as the sole check that themedication is correct, or may further be employed as an initialindication of medication, and then the pill or other medication imagingmay confirm that the medication pill or the like is consistent with, forexample, the bottle or label as well as a prescription, if appropriate.Furthermore, time on task, as well as any other anomalies determined inthe medication administration process may be employed to aid indetermining any problems with medication administration by the user.

Therefore, in accordance with one or more embodiments of the invention,determining patterns of behavior based on analysis of differentmovements, time on task, activities, or even micro movements, bulges, orother deformations in, for example the cheek of the user, or in anydetected or audio signals is provided. These patterns of behavior allprovide a longer term snapshot of the expected actions of the user, andallow for the determination of suspicious or other incorrect behaviorover time. Thus rather than simply considering a single action in time,consideration of actions of a user over time is contemplated inaccordance with the various embodiments of the invention. This time lineof actions gives a very different picture of activity of a user, andallows for the determination of consistency of action over time. Theseactions may further consider tracking of hand movements of the use, andremoval of medications from the packaging, such as a blister pack,bottle or the like. The above mentioned deep learning system, or othersupervised or unsupervised learning may be employed to allow for propertraining of the system, and/or for recognition and analysis of useractions. While the invention has been described making reference to pillmedications, capsules, sublingual medication, or medicationadministrable by any other route (such as inhalable or injectablemedication), may also be monitored in accordance with one or more of thevarious embodiments of the invention.

It is further contemplated that the system comprise one or moremedication reminders indicating to a user when it is time to take theirmedication. This reminder may be set by a healthcare provider, or by theuser. It is contemplated that the reminder be adjustable within apredefined window set in accordance with the medication prescription.Such flexibility may allow the user to set medication reminders to avoidother activities such as work and sleep.

In each of the above-described embodiments, various escalations for whenmedication is not taken properly may include one or more of an automatedcontact, personal contact, request for retraining or the like. Such anescalation process may be predefined, and therefore be automated,prompting intervention and input from a healthcare provider whenwarranted. In such a manner, the system allows a large number of usersto be monitored by a relatively small number of healthcare professionalsaided by the inventive system. The system further preferably logsinterventions, whether automated or personal, in order to determine fora particular user or group of users, which intervention strategy is mosteffective. Thus, through the application of such an escalation procedureto a number of users, a most effective escalation process can be definedand applied on a go-forward basis, thus allowing for continual tweakingof the system to provide a most effective monitoring and interventionsystem.

In addition to monitoring administration, the system may further requestvarious feedback from the user, relating to reasons for skippingmedication, side effects, or any other information. Such additionalinformation may be employed to further customize the escalation processto improve the ability of the system and healthcare provider toencourage proper medication adherence.

In addition to monitoring medication administration, the system may alsoreceive information from one or more medication monitoring devices, suchas, but not limited to, glucose monitors, heart rate monitors and thelike. These systems may transfer information to the system via awireless protocol such Wi-Fi, Bluetooth, or the like, or the system mayimage a display from one or more of these devices to read theinformation presented thereon. Other devices, such as activity monitors,such as the Nike® fit band, FITBIT®, Jawbone UP™ wristband and the likemay further be employed to correlate user activity and medicationadherence. This information may be included as another input into adecision process that determines adherence, and when adherence fails, isable to correlate user activities, side effects, lack of consistency inmedication administration and the like to predict participants who mayhave future adherence problems. These users may then be contacted toward off the expected future adherence problems. This information may beused to adjust a prescription, either timing, amount, both, or the like.The information may be further used to predict future adherence to themedication protocol.

While the invention has been described relative to a camera on a mobiledevice, preferably a smart phone, tablet computing device, or the like,other electronic devices including an image capture device for imagingthe medication administration process and providing instructions andother feedback to the user may be employed. Thus, a smart watch, orother device including an image capture device such as a camera andfeedback mechanism thereon may be employed in accordance with thevarious embodiments of the invention. Portable and/or wearable computingdevices, such a Google Glass® may be employed to allow for imaging andidentification of medication, and for tracking various aspects of themedication administration process. Such a device may be employed inconjunction with an image capture device and other mobile device, thusproviding significant additional information to the system to aid inpredicting adherence behavior.

Information may further be read from any self-administration medical orother devices having a display thereon, thus by visual imaging, or byconnectivity through a local network, or through point to pointcommunications. Chips on pills (such as those currently provided byProteus Digital Health), one or more electronic pill bottle devicesconfirming the timing of opening of a pill bottle, breathalyzer typedevices, such as those provided by Exhale, RFID tags provided inmedication packaging, and other adherence monitoring devices may allprovide information to the devices and system of the current invention.It is contemplated, in a manner as noted above, that this variousinformation will be provided to allow for tuning of various escalationprocedures, thus providing a most effective monitoring and interventionsystem.

In addition to receiving various information, it is further contemplatedin accordance with the various embodiments of the invention that adashboard is provided to a healthcare provider or other individual whohas interest in the adherence monitoring of the user. All adherence andmedication administration is preferably accumulated and displayed to thehealthcare provider or other individual on a dashboard-type display.Recommended intervention strategies are also provided to the healthcareprovider. In a manner as noted above, these customized interventionstrategies may be determined in accordance with one or more ofhistorical adherence for the particular user, historical adherence forthe demographic group, disease state, or the like. The healthcareprovider or other individual may be provided one or more charts, tablesor other information displays to allow for assisted review of theaccumulated adherence information. As noted above, by allowing directintervention and contact with a user via such a dashboard, this not onlylightens the burden on the healthcare provider, but also allows forresults of various interventions to be tracked and optimized.

The system and dashboard may further allow for the healthcare provideror other individual to receive automated alerts when one or more usershas a medication adherence event, or requires intervention or follow up.Thus, the healthcare provider or other individual may receive an emailor text message when intervention is recommended. A mobile applicationversion may allow the healthcare provider or other individual tointeract with the user via their mobile device, thus allowing forlogging and monitoring of any such interventions, while allowing for theflexibility of intervention using a mobile or other convenient device.

Therefore, in accordance with one or more embodiments of the invention,a system to allow for a holistic approach to medication adherence isprovided. Adherence monitoring is provided using facial recognition,computer vision and activity recognition, in a non-invasive manner.Adherence information for each individual is accumulated and provided,both individually and in an aggregated manner to a healthcare provideror other individual. Targeted and custom interventions are recommendedbased upon predictive algorithms that aid in determining when a usermight be at risk for poor adherence in the future. Interventions throughthe system are tracked and analyzed to determine which result in thebest future corrective behavior of a user. This information is employedin a feedback to improve and optimize intervention and escalationstrategies for the individual user, as well as other user similarlysituated with at least one attribute. These optimized interventions aretherefore designed to be as non-intrusive as possible while eliciting achange in behavior of the user where change is still possible, andbefore adherence problems may render prescribed medication ineffective.

While the system has been described employing one or more local deviceson the part of the user, cloud based systems allowing the user tointeract with the system employing an Internet browser or other remoteconnection program may be employed. Healthcare providers or otherindividuals may similarly access various information via a cloud basedsystem, or through information pushed to a local device.

Additionally, referring to FIG. 5, a display and image capture apparatus500 that may be employed in accordance with one or more embodiments ofthe present invention for acquiring one or more images, and fordisplaying the one or more images and additional material, forperforming processing in accordance with the various embodiments of theinvention, and for storing computer program instructions, acquired data,and other information on a non-volatile computer readable storage mediumis shown. Apparatus 500 preferably includes a housing 510, an imagecapture device such as an image capture camera 520, and a display orother information presentation device 530 for presenting informationvisually and/or audibly. Image capture camera 520 may comprise a singlecamera element, a stereo camera element or other appropriate imagecapture device. Other elements, as known to one of ordinary skill in theart, including ports, power attachments, processors for processing data,and the like may also be provided in accordance with apparatus 500. Itis further contemplated in accordance with the various embodiments ofthe invention that apparatus may include one or more self-checkmechanisms, including mechanisms for determining proper ambient light,direction and background of the camera and the background imaged by thecamera, or other environmental issues that may be improved to furtheraid in the imaging of any images by apparatus 500. Additionally, if atany time it is determined that lighting conditions are too difficult forimaging apparatus 500, it may be possible to provide a light burst froma strobe or display to aid in illuminating the images to be captured.The above descriptions of the various embodiments of the invention willassume that such a display and image capture apparatus 500 may beemployed. The invention, however, shall not be so limited and may beemployed on any structure of image capture camera and display, whethercontained in a single or multiple apparatuses, or any other appropriatesystem for capturing images and providing processing as described above.Furthermore, it is contemplated in accordance with the invention thatimage capture and processing may be implemented in a cloud computingenvironment, with an image capture device forwarding captured images toa remote location for storage and processing. Responses contemplated inaccordance with the above description may be provided to the imagecapture device in manners known to those of ordinary skill in the art.

Therefore, in accordance with the invention, a method and apparatus areprovided that allow for the automated confirmation of a user placing apill in their mouth, for environments that have high or low computingpower.

It will thus be seen that the objects set forth above, among those madeapparent from the preceding description, are efficiently attained and,because certain changes may be made in carrying out the above method andin the construction(s) set forth without departing from the spirit andscope of the invention, it is intended that all matter contained in theabove description and shown in the accompanying drawings shall beinterpreted as illustrative and not in a limiting sense.

It is also to be understood that this description and following claimsare intended to cover all of the generic and specific features of theinvention herein described and all statements of the scope of theinvention which, as a matter of language, might be said to fall therebetween.

What is claimed is:
 1. A display and image capture apparatus formonitoring medication adherence of a user, comprising: an image capturedevice for capturing one or more video sequences associated withadministration of medication by the user; a computer processorassociated with the image capture device arranged to receive thecaptured one or more video sequences, and to determine, based at leastin part on the captured one or more video sequences, whether the userhas properly performed a predetermined portion of a predeterminedprocess representative of proper medication adherence by the user; and apresentation device, associated with the image capture device, arrangedto present visually to the user one or more instructions encouragingproper performance of the predetermined portion of the predeterminedprocess representative of proper medication adherence if the computerprocessor has determined that the user has not properly performed thepredetermined portion of the predetermined process.
 2. The apparatus ofclaim 1, wherein the computer processor is operable to determine whetherthe user has performed the predetermined portion of the predeterminedprocess representative of proper medication adherence by determining atleast one of: (i) that the user has properly positioned the user's facein a field of view of the image capture device, (ii) that the user hasproperly positioned a pill in the field of view of the image capturedevice, (iii) that the user has properly placed the pill in the user'smouth, (iv) that the user has properly drank a glass of liquid in thefield of view of the image capture device, or (v) that the user hasproperly displayed the user's empty mouth in the field of view of theimage capture device.
 3. The apparatus of claim 2, wherein the computerprocessor is operable to determine that the user has properly placed thepill in the user's mouth by extracting one or more features associatedwith the pill, determining a confidence score for each of the one ormore features representative of a likelihood that the pill captured inthe one or more video sequences is a predetermined type of pill, andperforming a decision fusion process on all of the determined confidencescores to determine whether the pill is a proper pill.
 4. The apparatusof claim 2, wherein the computer processor is operable to determine, inaccordance with a deep learning analysis system for extracting one ormore features associated with the pill, that the user has properlyplaced the pill in the user's mouth and to determine whether the pill isa proper pill.
 5. The apparatus of claim 2, wherein the computerprocessor is operable to determine that the user has properly placed thepill in the user's mouth by extracting one or more features associatedwith the pill, performing a feature fusion process on all of the one ormore extracted features associated with the pill, and determining ascore in accordance with the one or more extracted features to determinewhether the pill is a proper pill.
 6. The apparatus of claim 1, furthercomprising a communication system for transmitting one or moreindications related to performance of the predetermined portion of thepredetermined process to a remote location.
 7. The apparatus of claim 6,comprising a computer processor at a remote location, wherein thecomputer processor at the remote location is operable to performadditional processing on the transmitted one or more indications relatedto performance of the predetermined portion of the predeterminedprocess, and to transmit to the display and image capture apparatus oneor more results of the additional processing.
 8. The apparatus of claim1, further comprising a communication system for transmitting thecaptured one or more video sequences to a remote location.
 9. Theapparatus of claim 8 arranged to transmit the captured one or more videosequences to the remote location over a series of administrations. 10.The apparatus of claim 9, comprising a computer processor at the remotelocation, wherein the computer processor at the remote location isoperable to determine whether the user has properly administered themedication in accordance with the series of administrations.
 11. Theapparatus of claim 10, wherein the computer processor at the remotelocation is operable to extract one or more suspicious activityindicators in accordance with the series of administrations.
 12. Theapparatus of claim 11, wherein the apparatus is arranged to report theextracted one or more suspicious activity indicators to a third party.13. The apparatus of claim 11, wherein the one or more suspiciousactivity indicators are selected from a group consisting of: handmovement, mouth movement, cheek shape, swallowing, audio sounds, facemovement, and time on task.
 14. The apparatus of claim 1, wherein thepredetermined portion of the predetermined process comprises intake ofmedication into the user's body, and wherein the intake of themedication into the user's body includes ingestion of the medicationorally by the user.
 15. The apparatus of claim 1, wherein thepresentation device is further arranged to present audibly to the userone or more instruction encouraging proper performance of thepredetermined portion of the predetermined process representative ofproper medication adherence in response to the computer processor'sdetermining that the user has not properly performed the predeterminedportion of the predetermined process, and arranged to present audibly anacknowledgment of proper performance of the predetermined portion of thepredetermined process representative of proper medication adherence inresponse to the computer processor's determining that the user hasproperly performed the predetermined portion of the predeterminedprocess.